BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    GAMBRO HEMOFREEZE-BAG

    FDA 510(k)
    FDA Class 2 ·Hematology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·10842209102812·

    U-CLIP UNI-FIRE, MODEL M65

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MPS DELIVERY SET

    FDA Adverse Event
    Malfunction ·QUEST MEDICAL, INC.·Product code DTR·August 28, 2020

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 8, 2014

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·October 17, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 11, 2007

    MPS DELIVERY SET WITH ARREST/AGENT CASSETTES AND 183CM TABLE LINE

    FDA Adverse Event
    Injury ·QUEST MEDICAL, INC.·Product code DTR·April 28, 2016

    MPS DELIVERY SET WITH ARREST/AGENT CASSETTES AND 183CM TABLE LINE

    FDA Adverse Event
    Malfunction ·QUEST MEDICAL, INC.·Product code DTR·April 28, 2016

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012